Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
100

Summary

Conditions
Acute Ischemic Stroke
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study is a multicenter, prospective observational study. The study period is 12 months. There are no investigational products to be followed or used in the study. Demographic data, stroke subtype, lesion localization, anthropometric measures will be recorded. Muscle in three different anatomica...

This study is a multicenter, prospective observational study. The study period is 12 months. There are no investigational products to be followed or used in the study. Demographic data, stroke subtype, lesion localization, anthropometric measures will be recorded. Muscle in three different anatomical sites will be measured by CT following admission in patients included in the study. For anthropometric measurements, height, body weight, body mass index, waist circumference, triceps skin thickness and calf circumference values will be used. The muscle mass will be measured from the paraspinal muscles at the L3 vertebra level and from the muscles around the humerus and femur on the non-paralytic side of the extremities by CT. All patients will receive standard enteral nutritional support with a standardized calorie and protein-based protocol recommended by international guidelines. The choice of the commercial enteral product will be left to the investigator, without any encouragement or restriction for use of any commercial product. The enteral nutrition protocol will be implemented as follows; Nasogastric or nasojejunal access Continuous infusion Targeted daily calories - 25-30 kcal / kg Targeted daily protein - 1.2-1.5 gr / kg 20 ml / h initial infusion rate Increase infusion rate by 10-20 ml / h in 8-12 hours Targeted calorie-protein requirement will be reached at the end of 72 hours. Patients will continue their routine follow-up in the neurology intensive care unit / stroke unit / neurology department. Daily enteral nutrition dose, complications attributed to enteral nutrition and systemic comorbidities will be recorded. Anthropometric measurements and muscle mass measurements with CT at three different locations will be repeated at the end of the second week (14 days ± 3 days) . The study will evaluate whether or not muscle mass develops 14 days after acute ischemic stroke. The end points of the study is deterioration of anthropometric measurements and loss of muscle mass demonstrated by CT at follow up. The differences between patients with and without muscle loss will be assessed from the the aspects of demographic characteristics, ischemic stroke subtype, comorbidities and the success attained in reaching enteral nutritional goals.

Tracking Information

NCT #
NCT03825419
Collaborators
  • Abbott Nutrition
  • Klinar CRO
  • Turkish Neurological Society
Investigators
Not Provided